off-label
Beyond approved uses
Off-label describes the use of a medication or medical device for a purpose not approved by regulatory agencies.
A doctor might prescribe an antidepressant off-label for chronic pain, or a blood pressure drug for anxiety.
The practice is legal and common—regulatory approval covers specific uses, but physicians may prescribe based on emerging research or clinical experience: The drug is used off-label to treat migraines.
Medical dispensing authorization
- medicationTherapeutic substance for illness
- unapprovedNot officially permitted
- experimentalTesting new methods
- indicationSign of what's coming
dosage · formulation · therapeutic · repurpose · drug · treatment · nonapproved · unlicensed
New and unusual
- repurposingAdapting for different use
- discoveryAct of finding something
- breakthroughSudden important advance
- serendipitousFortunately coincidental
pioneering · experimental · investigational · promising · emerging · cutting-edge · repositioning · creative
U.S. health regulator
- approvalFavorable opinion given
- complianceAdhering to requirements
- oversightSupervision or inadvertent omission
- authorizationFormal permission granted
guidelines · sanctioned · unauthorized · unregulated · unsanctioned · clearance · indication · monitoring
Formally ordering treatment
- clinicalEmotionally detached, medically precise
- physicianLicensed medical doctor
- discretionCareful judgment in speech
- judgmentReasoned decision-making capacity
patient · evidence-based · anecdotal · trial-and-error · protocol · malpractice · liability · documentation
prescription
Medical dispensing authorization
- medicationTherapeutic substance for illness
- unapprovedNot officially permitted
- experimentalTesting new methods
indication · dosage · formulation · therapeutic · repurpose · drug · treatment · nonapproved · unlicensed · unindicated
novel
New and unusual
- repurposingAdapting for different use
- discoveryAct of finding something
- breakthroughSudden important advance
serendipitous · pioneering · experimental · investigational · promising · emerging · cutting-edge · repositioning · creative · resourceful
FDA
U.S. health regulator
- approvalFavorable opinion given
- complianceAdhering to requirements
- oversightSupervision or inadvertent omission
authorization · guidelines · sanctioned · unauthorized · unregulated · unsanctioned · clearance · indication · monitoring · post-market
prescribing
Formally ordering treatment
- clinicalEmotionally detached, medically precise
- physicianLicensed medical doctor
- discretionCareful judgment in speech
judgment · patient · evidence-based · anecdotal · trial-and-error · protocol · malpractice · liability · documentation · rationale
- trade statusapproved, authorized, banned, certified, cleared
- FDAdrug approval, approval letter, drug recall, recalls, labeling laws
off-labelapproved
Officially accepted or permitted
indicated · licensed · authorized · sanctioned · registered
label, labelling, off-road, unlabeled, relabel, off-season, mislabel, relabeling, mislabeling